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Evaluation of Non-Invasive Ventilation Preoperative Lung Resection Surgery


N/A
18 Years
N/A
Open (Enrolling)
Both
Surgery for Primary Lung Cancer

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Trial Information

Evaluation of Non-Invasive Ventilation Preoperative Lung Resection Surgery


Inclusion Criteria:



- Patient over 18 years, to benefit from surgery scheduled for lung resection
(lobectomy or segmentectomy) for primary lung cancer and having signed an informed
consent.

AND

- Trouble obstructive (FEV / FVC <70% and FEV <80% predicted)

Or restrictive (FVC <80% or TLC <80%)

Or decrease in the ratio TLCO / VA <60%

Or history of respiratory failure with hypercapnic Pa CO2> 45 mmHg in the year preceding
surgery

Or long-term oxygen

Or heart failure (clinical signs of heart failure and LVEF <55% or disorder of relaxation
on echocardiography or atrial fibrillation)

Or history of acute cardiogenic pulmonary edema.

Or obesity (BMI> 30 kg/m2)

Exclusion Criteria:

- Inability to consent

- Patient declared inoperable given the comorbidities or refusing surgery or with
unresectable tumors.

- Patient operable but with no comorbidities described in the inclusion criteria

- Contraindications to the non-invasive ventilation:

- Lack of understanding of the technical

- facial malformation

- Tight stenosis of the upper airway

- uncontrollable vomiting

- Unable to remove the mask

- Cognitive impairment or severe psychiatric jeopardizing the observance of the
NAV

- Patient non-insured

- Patient already on invasive ventilation or non-invasive

- During Pregnancy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reduction of pulmonary complications and cardiovascular postoperative

Outcome Description:

Demonstrate that the non-invasive ventilation in two pressure levels achieved during at least 7 days before surgery lung resection (lobectomy or segmentectomy) halved the pulmonary and cardiovascular postoperative patients with obstructive ventilatory disorder or restrictive, obesity or chronic heart failure.

Outcome Time Frame:

1 month

Safety Issue:

Yes

Principal Investigator

Nicolas PALEIRON, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brest, Inter Army Hospital Clermont-Tonnerre

Authority:

France : ANSM - Agence Nationale de Sécutité du Médicament et des produits de santé

Study ID:

RB 11.095 préOVNI

NCT ID:

NCT01685580

Start Date:

October 2012

Completion Date:

February 2015

Related Keywords:

  • Surgery for Primary Lung Cancer
  • primary lung cancer
  • lobectomy
  • pneumonectomy
  • non-invasive ventilation
  • Lung Neoplasms

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